Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000513617
Ethics application status
Approved
Date submitted
21/04/2023
Date registered
18/05/2023
Date last updated
25/06/2024
Date data sharing statement initially provided
18/05/2023
Date results information initially provided
25/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Eat, Learn, Grow: a digital responsive feeding support program for parents and caregivers
Scientific title
Responsive Feeding in Tough Times: Promoting the use of responsive feeding practices by parents of infants experiencing food insecurity through the program Eat, Learn, Grow
Secondary ID [1] 309501 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Child Feeding 329777 0
Parental Feeding Practice 329778 0
Condition category
Condition code
Diet and Nutrition 326677 326677 0 0
Other diet and nutrition disorders
Public Health 326678 326678 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eat, Learn, Grow is a targeted, brief, digital intervention designed to promote responsive feeding practices among Australian families of young children (6 months - 24 months) who experience food insecurity or economic hardship.
Responsive feeding practices are those that attend to a child's cues of hunger and fullness and supports eating autonomy and self-regulation. Responsive feeding interventions have been shown to reduce fussy eating and increase fruit and vegetable intake. It is also thought to play a role in promoting healthy growth in children. Families who experience food insecurity have unique feeding challenges and experience poorer nutrition-related outcomes.

Eat, Learn, Grow has been co-designed with Australian families who experience economic hardship/food insecurity. It includes a series of short digital modules that will be delivered via SMS to the parent's mobile phone and a small supplementary package of materials including a booklet, toothbrush, intervention messaging stickers and a children's storybook (Goodnight Veggies, by Diana Murray ISBN: 9781839130434). The booklet has been designed by the research team for this project and includes the project’s contact details, key intervention messaging (i.e., What is responsive feeding and why it’s important; The roles of adults and baby/child in feeding; Young children need lots of chances to try food; Supporting young children to learn about food through sensory exploration/play; The benefits of role modelling and eating together) as well as links to further information to credible sites including The Raising Children’s Network (for comprehensive government endorsed parenting support), Oral health for babies and toddlers (the Australian Dental Association), Food Allergies (nip allergies in the bub), Recipe and cooking skills (no money, no time website from the University of Newcastle). The children’s storybook is included as an activity parents can do to expand their child’s experience with food (food literacy); it tells the story of saying good night to vegetables in a garden explaining where they grow and has illustrations to support this.
There are 12 digital modules, which take 3-5 minutes each to complete that will be sent out over 6 weeks to parents with the following schedule and content:
Week 1: 3 lessons (M, W, F)
1. Welcome: Objective - To make contact with participants and welcome to the program
Summary of contents:
• Objective of this resource is to support responsive feeding (RF)
• Introduce the team (Video)
• Advice given is generalised; seek local CHN/GP for individualised support
• Share these resources with your family
2. What is Responsive Feeding?: Objective: To become aware of the definition of responsive
Summary of contents:
• Responsive feeding and the key principles
• Babies are born with the capacity to self regulate food intake
• Adults can influence this capacity
• Definition of responsive feeding and basic principle
• Why use RF?
• Common baby hunger signs
• Common baby fullness signs
3. Responsive Feeding: What does it look like?: Objective - To reinforce the principles of RF and identify what is looks like in practice
Summary of Contents:
• Definition of RF
• Metaphor of RF is a conversation (back and forth)
• Structure to support RF
• Video of hunger and fullness signs
Week 2: 2 lessons (W, F)
4. Feeding Roles: Parent provides, child decides. Objective - To introduce Ellyn Satter’s Division of Responsibility in Feeding framework, identify the key components and how to apply it.
Summary of Contents:
• Division of responsibility can help parents navigate mealtimes
• Definition of feeding roles (parent and child) under the division of responsibility
• Eating is a learning process
5. Learning to eat takes time. Objective: To make parents aware that learning to eat a range of foods is a process that takes time, requires multiple exposure to foods and can regress during toddlerhood.
Summary of Contents:
• Babies can be enthusiastic eaters
• As babies move into toddlerhood it is normal to become more cautious with foods
• Acknowledge this is frustrating
• Parents can help support food acceptance by offering food multiple times without pressure
• Food wastage can be of concern
Week 3: 2 lessons (W, F)
6. Mealtimes are about more than food. Objective: To describe what is meant by a family meal, what are the benefits of regular family meals and strategies to do them more often
Summary of Contents:
• Family meals don’t have to be perfect or complicated
• Benefits of regular family mealtimes for parents and children, extend beyond eating
• Warmth and tone of the meal is important
• Strategies and tips for regular mealtimes
7. Let’s Eat Together: Role modelling. Objective: What is parental role modelling and why is it important for feeding?
Summary of Contents:
• What is role modelling?
• Who are role models?
• Why role modelling is important when it comes to children learning to eat
• Acknowledgement that eating together is not always possible and some of the reasons that get in the way (i.e., not enough food, conflicting schedules)
Week 4: 2 lessons (W, F)
8. Family Food Talk. Objective: To promote adults’ awareness that what they say about food and the strategies they use to get children to eat or not eat matter and can have a lasting impact on children’s eating behaviour
Summary of Contents:

• Food is central to many aspects of life (culture, celebrations, religion, connection)
• Parents sometimes use food to control child behaviour (rewards, bribes, punishments)
• What to do instead
• Having a neutral approach to food
9. Learning about food away from table. Objective: To teach parents that young children explore food through their senses and that this is important to become more familiar with food and to eat variety.
• Children learn about food both at the table (eating) and away from the table (playing)
• Ideas presented for how to support young children’s growing experience with food
• That learning about food can be messy
Week 5 2 lessons (W, F)
10. Variety. Objective: To describe what is meant by food variety, why it is important, and prompt parents to include more variety
Summary of Contents:
• Why is variety important
• 2 definitions of food variety (i.e., different foods within and between the 5 food groups)
• What are the 5 food groups
• Simple ways to include more variety
11. Being Creative. Objective: To share the experiences and tips for how they feed their family on a budget from the parents who codesigned the intervention.
Summary of Contents:
• Acknowledge that feeding the family can be expensive and challenging
• Being creative with food resources and cooking can help reduce the cost and stress
• What is meal planning
• Collated tips & strategies from parents
Week 6 Text msg (M); 1 Lesson (F)
Text Message –
• Include a reminder to ‘catch up’ on content
• To encourage parents to catch up on any mini lessons that they haven’t yet completed
• Reminder that the final ‘wrap up’ lesson is coming on Friday with the second survey
12. What’s next…Objective: To thank parents for their participation, recap the key messages, to remind them of the survey and why this is important
Summary of Contents:
• Reminder that these mini-lessons can be revisited whenever they like
• Recap: What is RF; What are the shared feeding roles; Children need lots of chances to try foods; Learning about food happens away from the table too; Family meals are important; Being creative with food
• Link to T1 survey

This intervention will be piloted in a feasibility randomised control trial of 150 participants with a wait listed control group. The digital modules draw on cognitive load and social learning theories to develop the content to optimise impact. The impact will be evaluated through a baseline, 6 week and 6 month online survey including sociodemographic factors, and validated tools for the primary outcome: parent feeding practice (Feeding Practice and Structure Questionnaire) and the mediating factors measured: food insecurity (United States Department Household Food Security Survey) and household chaos and dysfunction (Confusion, Hubbub and Organisation tool). Secondary outcome measures include infant dietary variety (EPOCH-Infant dietary Q - 2 items) and process evaluation factors including satisfaction, engagement and uptake, and acceptability of the digital mode. The intervention period is 6 weeks with a 6 month follow up. Engagement and uptake will include website analytics from the learning management system used to create and deliver the modules and will include: if the module link was opened, if it was completed, if questions/quizzes/polls were completed and what the responses were.
The intervention will be delivered remotely and the package will be mailed to participants. The content was developed by the research team who are dietitians with child feeding and parental feeding practice expertise and was reviewed by a committee of experts including child health nurses, dietitians, and a psychologist with parenting research experience.
This research program will be coordinated from a Brisbane hub and delivered Australia wide.
The pilot will run from May 2023 until adequately recruited for, it is expected that data collection will be until February 2024. The intervention content is a series of 12 short digital modules, which are web browser hosted, and includes videos, audio bites, and interactivity. The mailout package will be posted at the commencement of enrolment for the intervention group. The intervention has been designed for the target population of families with young children who experience food insecurity. The content is contextually sensitive to this experience and includes contributions by families with quotes and short story excerpts to bring families lived experience to the content and to promote practice through social learning.
Intervention code [1] 325929 0
Behaviour
Intervention code [2] 325930 0
Lifestyle
Intervention code [3] 325931 0
Prevention
Comparator / control treatment
Control group (wait listed). The control group will be invited to the intervention at 6 months
Control group
Active

Outcomes
Primary outcome [1] 334545 0
Parental feeding practice - responsiveness. The Feeding Practices and Structure Questionnaire (Jansen, E., Russell, C.G., Appleton, J. et al. The Feeding Practices and Structure Questionnaire: development and validation of age appropriate versions for infants and toddlers. Int J Behav Nutr Phys Act 18, 13 (2021). https://doi.org/10.1186/s12966-021-01079-x)
Timepoint [1] 334545 0
Baseline, 6 weeks post intervention commencement and 6 months post intervention commencement
Secondary outcome [1] 421054 0
Uptake (% opened and % completed modules)
These data will be sourced from the Learning Management System website analytics
Timepoint [1] 421054 0
6 weeks post intervention commencement (intervention group only)
Secondary outcome [2] 421055 0
Satisfaction scores
sourced from the process question series in the evaluation survey, including:
How would you rate the quality of Eat, Learn, Grow? 7 point Likert scale response
How satisfied were you with Eat, Learn, Grow? 7 point Likert scale response
Timepoint [2] 421055 0
6 weeks post intervention commencement (intervention group only)
Secondary outcome [3] 421056 0
Dietary variety (vegetables) EPOCH-Infant Dietary Questionnaire 2 items
Timepoint [3] 421056 0
Baseline, 6 weeks post intervention commencement and 6 months post intervention commencement
Secondary outcome [4] 421057 0
Food Resource Management Skills (USDA subscale 6 items)
Timepoint [4] 421057 0
Baseline, 6 weeks post intervention commencement and 6 months post intervention commencement
Secondary outcome [5] 421814 0
Acceptability scores:
sourced from the process question series in the evaluation survey, including:
To what extent has Eat, Learn, Grow met your needs? 7 point Likert scale response
How helpful was the Eat, Learn, Grow program? 7 point Likert scale response
Timepoint [5] 421814 0
6 weeks post intervention commencement (intervention group only)

Eligibility
Key inclusion criteria
1. Parent or caregiver of a child aged 6 months to 24 months
2. Experiencing economic hardship (assessed through the self-administered screening question of: Do you sometimes struggle to pay the bills?)
3. Direct access to a smart device (mobile phone or tablet)
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Individuals who are unable to give informed consent, for example, non-English speaking, requiring an interpreter, individuals with cognitive impairment
2. Where the child of interest has a medical condition which significantly impacts dietary intake or appetite regulation (e.g., severe allergy, Prader Willi syndrome)
3. Where the child of interest is born prematurely at >35 weeks gestation and/or <2500grams

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation to group will be concealed from researcher and participant until after consent and enrolment and the first baseline measures have been completed.
Method
- Sealed opaque envelopes
Participant will then be informed of allocation via phone call. Due to the nature of this research, allocation can not be concealed from this point.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a 1:1 ratio intervention to control group until the required number of participants has been enrolled
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Control group is wait listed and will be invited to undertake the program after the period of control is completed (i.e. 6 months)
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical Analysis- All analysis will be intention to treat.
No sample size has been calculated for this study design. This is a feasibility pilot trial, statistical advice indicated pilot trials of this nature have a recruitment target of n = 100 – 150. We have selected the upper limit of 150.
Descriptive statistics will be used to describe the sample demographics and responses to questionnaires and will be summarised as mean and S.D or median and IQR for data that is not normally distributed.
Parental Feeding Practices: Mean scores the following domains will be derived from the Feeding Practices and Structure Questionnaire [Jansen, E., Russell, C.G., Appleton, J. et al. The Feeding Practices and Structure Questionnaire: development and validation of age appropriate versions for infants and toddlers. Int J Behav Nutr Phys Act 18, 13 (2021). https://doi.org/10.1186/s12966-021-01079-x] – reward for behaviour, reward for eating, persuasive feeding, overt restriction, covert restriction, structured meal setting and structured meal timing, in relation to solid feeding/formula feeding/breastfeeding depending how the child is currently fed. Scale reliability will be assessed using Cronbach’s alpha. Higher mean scores imply greater use of that feeding practice.
Assessment of Food insecurity: Items within the United States Department of Agriculture (USDA) Household Food Security Survey Module (USDA-HFSSM) [Radimer, K.L. and K.L. Radimer, Measurement of household food security in the USA and other industrialised countries. Public Health Nutrition, 2002. 5(6a): p. 859-864.] are re-coded into affirmative (score of 1) or negative (score of zero) responses according to the USDA coding scheme. Responses are summed to provide a continuous food-security scale, which measure the severity of food insecurity. “The condition of fully secure, which represents the absence of the measured condition, is assigned a scale value of zero” [Radimer, K.L. and K.L. Radimer, Measurement of household food security in the USA and other industrialised countries. Public Health Nutrition, 2002. 5(6a): p. 859-864.].
Positive responses to items within the Confusion, Hubub, and Order Scale (CHAOS) [Matheny, A.P., et al., Bringing order out of chaos: Psychometric characteristics of the confusion, hubbub, and order scale. Journal of Applied Developmental Psychology, 1995. 16(3): p. 429-444] can be summed to provide a total score of between 0 and 15, with higher scores indicating higher household chaos.

Linear Mixed models to compare differences in the scores for parental feeding practices from baseline to post intervention, between intervention and control group adjusted for: socio-demographic factors and household food insecurity.

Codesign workshops and interviews: Interviews/workshops will be audio-recorded or video recorded. In person engagement sessions will be audio recorded, remotely conducted sessions will be video recorded by recording the zoom videoconference meeting using zoom. These recordings will be transcribed verbatim using an automated transcription service that generates transcripts from audio files using artificial intelligence and machine learning (Otter.ai - https://otter.ai/). No data will be stored on the Otter.ai platform and both audio files and transcripts will be deleted off the platform as soon as the transcript is finalised. Both the transcript and audio file will be stored on the QUT secure share file, whereby only QUT research team members have access.
Transcripts will be thematically analysed using the framework method [Gale, N.K., Heath, G., Cameron, E. et al. Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC Med Res Methodol 13, 117 (2013). https://doi.org/10.1186/1471-2288-13-117] identifying themes related to parents experience of participating in the intervention. Team members will meet to review, define, and name the themes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/05/2023
Actual
20/05/2023
Date of last participant enrolment
Anticipated
1/09/2023
Actual
6/08/2023
Date of last data collection
Anticipated
30/03/2024
Actual
5/02/2024
Sample size
Target
150
Accrual to date
Final
150
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313692 0
Charities/Societies/Foundations
Name [1] 313692 0
Children's Hospital Foundation through a philanthropic grant from Woolworths
Country [1] 313692 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Centre for Children's Health Research
Level 6, 62 Graham Street
South Brisbane
Queensland 4101
Country
Australia
Secondary sponsor category [1] 315499 0
Hospital
Name [1] 315499 0
Children's Health Queensland
Address [1] 315499 0
501 Stanley St, South Brisbane QLD 4101
Country [1] 315499 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312858 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Committee (EC00175)
Ethics committee address [1] 312858 0
CHQ HHS Human Research Ethics Committee
Centre for Children’s Health Research
Queensland Children’s Hospital Precinct
Level 7, 62 Graham Street
South Brisbane QLD 4101
Ethics committee country [1] 312858 0
Australia
Date submitted for ethics approval [1] 312858 0
08/03/2023
Approval date [1] 312858 0
17/04/2023
Ethics approval number [1] 312858 0
HREC/23/QCHQ/94215
Ethics committee name [2] 312859 0
Queensland University of Technology University Human Research Ethics Committee (EC00171)
Ethics committee address [2] 312859 0
149 Victoria Park Rd, Kelvin Grove QLD 4059
Ethics committee country [2] 312859 0
Australia
Date submitted for ethics approval [2] 312859 0
17/04/2023
Approval date [2] 312859 0
21/04/2023
Ethics approval number [2] 312859 0
7084

Summary
Brief summary
Responsive feeding practices among parents have been shown to improve child eating behaviours and diet quality. Responsive practices are those that attend to a child’s hunger and fullness cues, such as allowing a child to decide how much they eat, rather than pressuring them. Families who experience economic hardship or food insecurity face challenges in child feeding.

Aim: Eat, Learn, Grow will design and evaluate an intervention to support parents with economic hardship to use responsive feeding practices. This research program includes 2 phases: Phase I (ethics approval ref: LNR/21/QCHQ/72314): exploratory data collection and co-design of the intervention with parents; and Phase II (ethics approval ref: HREC/23/QCHQ/94215): evaluation of the co-designed intervention.

Outcomes: The primary outcome measure is feeding practice - parental responsiveness. Secondary outcomes are uptake, acceptability, and satisfaction. Mediating variables are sociodemographic factors, household food security and chaos.

Design: The intervention is called Eat, Learn, Grow and is a brief, low intensity program that includes a series of digital modules delivered via mobile phone with a supplementary mail out package. A randomised controlled trial design (n=150) will be used to pilot the program. Comparative analysis of the control and intervention groups over 3 time points (baseline, 6 weeks, 6 months) will be used as the basis of the evaluation. An online survey using REDCap will be used to collect sociodemographic information, the primary outcome measure and the mediating factors in the control and intervention groups. Validated tools are used to measure parental feeding practices, household food security, and chaos. The control will be wait listed and offered the intervention at the end of the 6 months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126154 0
Dr Rebecca Byrne
Address 126154 0
Queensland University of Technology
Centre for Children's Health Research
Level 6, 62 Graham Street
South Brisbane
QLD 4101
Country 126154 0
Australia
Phone 126154 0
+61 403934422
Fax 126154 0
Email 126154 0
[email protected]
Contact person for public queries
Name 126155 0
Dr Kimberley Baxter
Address 126155 0
Queensland University of Technology
Centre for Children's Health Research
Level 6, 62 Graham Street
South Brisbane
QLD 4101
Country 126155 0
Australia
Phone 126155 0
+61 478003209
Fax 126155 0
Email 126155 0
[email protected]
Contact person for scientific queries
Name 126156 0
Dr Kimberley Baxter
Address 126156 0
Queensland University of Technology
Centre for Children's Health Research
Level 6, 62 Graham Street
South Brisbane
QLD 4101
Country 126156 0
Australia
Phone 126156 0
+61 478003209
Fax 126156 0
Email 126156 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
de-identified, clean quantitative data from this research study will be shared in the QUT data repository https://researchdatafinder.qut.edu.au/
All de-identified (name, DOB, email address removed) quantitative data will be shared, additional data that may together be used to identify individuals will also be removed (post code, child DOB, specific ethnicity)
When will data be available (start and end dates)?
Data will be added at the completion of data collection, cleaning and analysis. No end date is specified for availability
Available to whom?
Data will be available by request only. The QUT data repository is an open web based platform that can be accessed by anyone. The front end of the datasets include project description, project team members, contact person, publications, geographical area research was conducted, research area, partner institutions, citation, date data record was created and modified, data type (e.g. .xls).
Available for what types of analyses?
Requests for data access will be assess on a per request basis, analyses that are relevant to the research area will be considered as per our protocol and ethics applications
How or where can data be obtained?
https://researchdatafinder.qut.edu.au/
Data will be stored securely in the QUT data repository, which will be accompanied by a project descriptor; this will include the contact person and their email address. Enquiries regarding access will be required via the named email, which will be Associate Professor Rebecca Byrne at [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.